This invention relates in general to enema administering procedures and apparata and in particular to enema tip improvements and administering techniques associated with double contrast studies.
Enema administering apparata are often used to control the rectal introduction of a contrast medium such as barium for such procedures as X-ray examination of the colon. While a variety of problems may be encountered with incontinent patients, one problem involves the inability of such patients to retain the enema tip during a fluoroscopy examination. Various solutions to this problem have been provided by the improved enema administering apparata disclosed in my copending patent application, Ser. No. 39,280, filed on May 16, 1979.
Another problem which is applicable to virtually all patients is the time lapse between preevacuation and postevacuation X-ray films when an air contrast study is required. Frequently referred to as a "double contrast" enema or fluoroscopy procedure, such a routine involves a conventional barium enema first, followed by an injection of air once the barium is evacuated. X-ray films are taken just prior to evacuation, air is then injected and postevacuation X-ray films are taken. An undue elapse of time between the preevacuation and postevacuation films allows the barium to dehydrate partially on the walls of the bowel when the air is injected. This results in highly unsatisfactory radiographs. Therefore, it would be an improvement to the various apparata currently used, as well as the procedures presently followed, if means where available for a rapid evacuation and prompt injection of air.
With currently used air-contrast apparata and procedures, the enema tube and tip are used for both the barium as well as for the air, and there is normally a separate air tube or passageway which is coupled to air introducing means. One problem with such an arrangement is that the air tube extends through the barium (or other contrast medium) passageway and partially blocks or impedes the flow of medium (barium). Furthermore, if suction is used for evacuation via the contrast medium passageway, some of the contrast medium may clog the air tube. Therefore, it would be an improvement to provide an air tube or air passageway as part of an enema tube and tip which does not interfere with the introduction of the contrast medium into the patient nor become clogged upon contrast medium evacuation.
This improvement can be accomplished by suitably spacing the contrast medium passageway and air tube so that the evacuation of contrast medium would not cause significant flow of contrast medium around or into the air tube.
Avoidance of clogging of the air tube can also be accomplished by providing a suitable type of valve which keeps the air tube shut while the contrast medium is being evacuated. This valve then allows the passage of air into the patient.
This valve function can be accomplished by the use of a damper with a living hinge which is in a normally closed condition and disposed over the air outlet opening. This damper precludes the flow of contrast medium into the air passageway during the evacuation procedure. Subsequently, the force of the air flowing through the air passageway pushes the damper open as it pivots about its living hinge. Another style of valve suitable for use is a ball valve. Still another style of valve means suitable for use are normally closed flexible lips. These lips may be disposed as part of the enema tip or alternatively as part of the air tube. The introduced air flow forces the lips open thus allowing the flow of air into the patient.
The foregoing valve means concept overcomes those problems associated with prior air introduction means. A simple flap can be used for a valve and when disposed in a normally closed condition precludes the entry of barium into the air passageway. The beauty of this idea is that existing enema tips can be retrofitted with such valves and thereby become suitable for successful double contrast studies.
Another problem with some presently used enema apparata is the lack of uniformity in tubing size for the tubing that is used to connect the tip with the enema bag. To alleviate this problem, an adapter can be used to interface directly between a standard sized tip and a variable-sized enema bag tubing. In this way, a simple, inexpensive set of adapters can be stored and used to easily and conveniently couple the enema tip directly to any size of tubing that is provided with the enema bag.
Another problem which often occurs involves the size and length of the enema-administering apparatus. Usually the apparatus includes a six foot long enema tube which connects the enema tip with the barium bag. These long lengths of tubing are cumbersome, and cause a great deal of barium to be wasted, because some of the barium remains in the tubing. The long tubing also tends to develop kinks which may restrict the flow of barium. A related concern is the size of the enema bag that holds the barium. A large barium bag has to be used because barium is wasted by just filling the long tubes. For these reasons, a shorter tube and a smaller bag would provide for efficiency, ease of use and patient comfort.
A related problem with present apparata is that someone has to hold the barium bag below the level of the patient's bowels in order to allow for the barium to drain out of the patient during the evacuation step. With the longer lengths of tubing, the bag is usually placed on the floor. With slightly shorter lengths, the patient has to hold the bag. Because this is awkward and many patients tend to be older, this approach is not really acceptable. Therefore, means are needed so that the bag can be secured at some point sufficiently below the patient's rectum so as to achieve proper drainage. One way to achieve this is provide a strap as part of the barium bag which is then tied around the patient's leg. A belt tied around the patient's waist with a hanging strap with notches in it can also be used. The barium bag is then hung on the approriate notch at an appropriate height.
The use of a smaller bag and shorter tube also allows for the use of the bag as means for shipping a single dosage of premixed barium within the actual bag. This will eliminate the necessity of preparing the bag initially. Smaller bags would also be less expensive to ship.
There are various enema-related apparata which have been conceived as set forth by the disclosures of the following listed patents. However, none of these disclosures set forth a device with advantages equal to the advantages of the present invention to be described in detail hereinafter. Thus, the present invention is an improvement to all prior art devices of which the inventor is aware.
______________________________________ U.S. Pat. No. Patentee Issue Date ______________________________________ 4,117,847 Clayton 10/03/78 3,707,146 Cook et al. 12/26/72 3,766,920 Greene 10/23/73 3,788,328 Alley et al. 1/29/74 4,090,502 Tajika 5/23/78 3,509,884 Bell 5/05/70 3,078,848 Milbert 2/26/63 3,769,962 McVey 11/06/73 4,044,757 McWhorter et al. 8/30/77 3,915,152 Colonna 10/28/75 3,760,805 Higuchi 9/25/73 3,752,146 Kline 8/14/73 3,844,284 Schoenfeld et al. 10/29/74 4,068,662 Sneider 1/17/78 4,014,332 Sneider 3/29/77 3,459,175 Miller 8/05/69 3,375,823 Pamplin et al. 4/02/68 2,112,160 Johnson 3/22/38 ______________________________________
Clayton discloses improvements in colon catheters for removing waste colon materials and includes a hollow main tube which is insertable into the anal opening and is held therein by an inflatable member located within the anal opening and by limiting elements located outside of the anal opening and extending for and aft from the main tube. An irrigation tube or the like is provided for directing enema fluid into the rectum above the inserted catheter.
Cook et al. discloses a means to inject a plastic into a cavity to produce a replica thereof and is particularly suitable to produce a soft resilient plastic impression of the interior configuration of a body cavity. An air bulb is provided and connected to the injection syringe by a section of tubing wherein the tubing exits at an inflatable cuff which is used to prevent inadvertent withdraw of the catheter during the injection operation.
Greene discloses a smooth, flexible enema tip having an inflatable balloon mounted on the stem behind the exit port from the tip. A limited volume, flexible hand distendable air reservoir is connected to the balloon-like retention ring so that operator compression of the reservoir will inflate the ring.
Alley et al. discloses a cardiovascular catheter for use particularly in open-heart surgery and related operations requiring varying forms of cardiopulmonary bypass. The catheter has a fixed ring provided on the catheter proximal to drainage inlets and may have a sliding ring snug fit on the catheter proximal to the fixed ring for securing the catheter to a penetrated portion of the anatomy, such as the heart wall, between the two rings to assist in holding the catheter in place.
Tajika discloses a remote-controlled barium injection apparatus for the injection of barium into the lower digestive tract of a patient to be examined and for the subsequent reflux and evacuation of the barium by air compression. The objective is to create greater safety in the production of double contrast studies or fluoroscopic examination. The apparatus employs detachable anal insert units which are the only portion of the apparatus in direct contact with a patient.
Bell discloses a rectal balloon catheter with inflatable stop or limit means for limiting the depth of insertion of the catheter into a body cavity to a predetermined maximal depth.
Milbert discloses a medical applicator which includes a multiple-position valve disposed in line between three tubing sections. One section of tubing couples to a fluid bag and the other two sections of tubing extend to remote use locations for this fluid. By selective positioning of the valve component, the fluid may be coupled to one or the other of the two remote use locations or may be closed off completely.
McVey discloses a barium enema administration method and apparatus which includes a three-way union of conduits, one conduit is connected to a gravity feed barium supply source, another conduit is connected to a source of air under pressure and the last conduit is an evacuation line connected to a source of suction. Each conduit is controlled by an individual valve and the valves are opened and closed in a prescribed sequence as directed by the radiologist.
McWhorter discloses a device for use in cholangiography and similar procedures comprising, a first syringe having a barrel defining a chamber for retaining an irrigation liquid and a plunger having one end received in the chamber for pumping the liquid from the chamber. The device has a second syringe having a barrel defining a chamber for retaining a liquid contrast medium and a plunger having one end received in the chamber of the second syringe for pumping the contrast medium from the chamber. The two syringes are jointly coupled to a catheter and this union may be provided with a selectably positionable valve.
Colonna discloses a barium device which includes lever means, barium supply means, valve means, piston means, squeeze bulb means and other components for providing a control system of barium in combination with air contrast for employment in the examination of patients.
Higuchi discloses an osmotic dispenser which includes a water-porous housing member confining a first flexible bag of relatively impervious material containing an active agent and provided with an active agent dispensing head and a second bag of controlled permeability to moisture containing a solution which exhibits an osmotic pressure gradient against water. A dual-compartment bag arrangement is illustrated in FIG. 4 and while the intended application and structure of such a dual-compartment bag arrangement is considerably different from the present invention, its general structure is of marginal relevancy.
Kline discloses a centrifuge tube formed from a transparent plastic and is provided at its bottom with a penetrable membrane through which an optical fiber element is passed upon completion of centrifuging of the contents to enable visual observation of the effective light, particularly ultra-violet light, on the contents. The body of the centrifuge tube has an accordion-like configuration.
Schoenfeld et al. discloses a disposable douche comprises of a collapsible bellows forming a syringe and containing a premeasured amount of cleansing powder and an elongated dispensing nozzle adapted to be secured to an open end of the bellows.
Sneider ('662) discloses improvements in accordion-style containers used with syringes, douches, and the like. The improvements pertain to both prefilled, disposable, reusable syringe and douche containers and accessories used therewith.
Sneider ('332) discloses a liquid-filled sealable flexible bag having a manipulative discharge tube or nozzle. The FIG. 9 illustration of the invention discloses an accordion-like receptacle which is coupled to a tubular member.
Miller discloses a device for giving an enema which includes an inflatable balloon received on a pipe having an undulating outer shape. The pipe includes a groove which receives an air tube and although this air tube is exterior of the contrast medium passageway for a portion of its length, the end of the air tube is disposed within the tip opening where the contrast medium exits.
Pamplin et al. discloses a dental syringe for selective discharging of dry air, water or spray. The air tube is disposed within the water passageway for substantially the full length of the passageway. The free end is closed by the air tube and a branch passageway allows the delivery of water from this closed end.
Johnson discloses a method and apparatus for effecting medicinal treatment which includes two flow channels in side-by-side relationship extending from two separate storage chambers to a common delivery tip location.